[Federal Register Volume 59, Number 249 (Thursday, December 29, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-32117]
[[Page Unknown]]
[Federal Register: December 29, 1994]
_______________________________________________________________________
Part X
Environmental Protection Agency
_______________________________________________________________________
Thirty-Fifth Report of the TSCA Interagency Testing Committee to the
Administrator Receipt of Report, Request for Comments, Solicitation of
Interested Parties in Developing Testing Consent Agreement; Notice
ENVIRONMENTAL PROTECTION AGENCY
[OPPTS-41042; FRL-4923-2]
Thirty-Fifth Report of the TSCA Interagency Testing Committee to
the Administrator Receipt of Report, Request for Comments, Solicitation
of Interested Parties in Developing Testing Consent Agreement
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The TSCA Interagency Testing Committee (ITC), established
under section 4(e) of the Toxic Substances Control Act (TSCA),
transmitted its Thirty-Fifth Report to the Administrator of EPA on
November 3, 1994. As noted in this Report, which is included with this
notice, the ITC revised the Priority Testing List by designating a
group of 25 chemicals to the List for priority consideration by the
Administrator for promulgation of test rules under section 4(a) of the
Act. These chemicals are designated for response within 12 months.
Therefore, in response to the ITC's designation, EPA will either
initiate rulemaking under section 4(a) of TSCA, enter into a testing
consent agreement, or publish a Federal Register notice explaining the
reasons for not initiating such rulemaking within 12 months. The ITC
also removed 110 of 123 previously recommended chemicals from the List.
The ITC removed 28 of 43 isocyanates, 27 of 89 aldehydes, 25 of 26
sulfones, 7 of 11 cyanoacrylates, 4 of 14 diaryl ethers and 19 of 35
chemicals originally recommended for subchronic (90-day) toxicity
testing. The ITC's reasons for removing these chemicals from the List
are listed in the Thirty-Fifth Report. There are no recommended with
intent-to-designate or recommended chemicals or chemical groups in the
Thirty-Fifth Report. EPA invites interested persons to submit written
comments on the Report.
In addition, EPA is soliciting interested parties for participation
in or monitoring of a TSCA section 4 testing consent agreement
development process for the chemicals that were designated for dermal
absorption testing. EPA is also inviting manufacturers and/or
processors of chemical substances who wish to participate in testing
negotiations for the chemicals designated for dermal absorption testing
to develop and submit testing agreement proposals to EPA.
DATES: Written comments on the Thirty-Fifth ITC Report should be
submitted by January 30, 1995. Written testing proposals must be
received by February 27, 1995. Written notice of interest in being
designated an ``interested party'' to the development or monitoring of
a consent agreement for the chemicals designated for dermal absorption
testing must be received by February 27, 1995. Those submitting written
testing proposals will be considered ``interested parties'' and do not
have to submit separate written notice. EPA will contact all
``interested parties'' and advise them of meeting dates.
ADDRESSES: Send six copies of written submissions to: TSCA
Nonconfidential Information Center (7407), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, Rm. B-607 NEM,
401 M St., SW., Washington, DC 20460. Submissions should bear the
document control number (OPPTS-41042; FRL-4923-2).
The public record supporting this action, including comments, is
available for public inspection in Rm. B-607 NEM at the address noted
above from 12 noon to 4 p.m., Monday through Friday, except legal
holidays.
FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director,
Environmental Assistance Division (7408), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 401 M St., SW.,
Rm. E-543B, Washington, DC 20460, (202) 554-1404, TDD (202) 554-0551.
SUPPLEMENTARY INFORMATION: EPA has received the TSCA Interagency
Testing Committee's Thirty-Fifth Report to the Administrator.
I. Background
TSCA (Pub. L. 94-469, 90 Stat. 2003 et seq; 15 U.S.C. 260l et seq.)
authorizes the Administrator of EPA to promulgate regulations under
section 4(a) requiring testing of chemicals and chemical groups in
order to develop data relevant to determining the risks that such
chemicals and chemical groups may present to health or the environment.
Section 4(e) of TSCA established the Interagency Testing Committee to
recommend chemicals and chemical groups to the Administrator of EPA for
priority testing consideration. Section 4(e) directs the ITC to revise
the TSCA section 4(e) Priority Testing List at least every 6 months.
The most recent revisions to this List are included in the ITC's
Thirty-Fifth Report. The Report was received by the Administrator on
November 3, 1994, and is included in this Notice. The Report designates
a group of 25 chemicals, and removes 110 of 123 previously recommended
chemicals from the TSCA section 4(e) Priority Testing List.
II. Written and Oral Comments
EPA invites interested persons to submit detailed comments on the
ITC's Report. All submissions should bear the identifying docket number
(OPPTS-41042).
EPA invites interested persons to submit detailed comments on the
ITC's new recommendations. The Agency is interested in receiving
information concerning additional or ongoing health and safety studies
on the subject chemicals as well as information relating to the human
and environmental exposure to these chemicals.
A notice will be published at a later date in the Federal Register
adding certain of the substances recommended in the ITC's Thirty-Fifth
Report to the TSCA section 8(d) Health and Safety Data Reporting Rule
(40 CFR part 716), which requires the reporting of unpublished health
and safety studies on the listed chemicals. That notice will also add
the chemicals to the TSCA section 8(a) Preliminary Assessment
Information Rule (40 CFR part 712). The section 8(a) rule requires the
reporting of production volume, use, exposure, and release information
on the listed chemicals.
III. Status of List
The ITC's Thirty-Fifth Report notes the designation of 25 chemicals
and the removal of 110 chemicals from the Priority Testing List. The
current TSCA section 4(e) Priority Testing List contains 13 chemicals
and 12 chemical groups, with 3 chemical groups and 3 chemicals
designated for testing.
IV. Testing Consent Agreements
1. Solicitation of interested parties. EPA's procedures for
requiring the testing of chemical substances under section 4 of TSCA
include the adoption of enforceable consent agreements and the
promulgation of test rules. These processes are found at 40 CFR 790.20.
EPA has on numerous occasions been approached by chemical companies
interested in negotiating consent agreements for testing ITC chemicals
or chemical groups. As a result of these requests, EPA is now inviting
persons interested in participating in or monitoring negotiations on
the chemical designated in the Thirty-Fifth ITC Report to notify EPA in
writing. Those who respond to this solicitation by the deadline
established in this notice will have the status of ``interested
parties'' and will be afforded opportunities to participate in the
negotiation process. These ``interested parties'' will not incur any
obligations by being designated ``interested parties.''
2. Solicitation of testing proposals for consent agreement
negotiations. EPA is also now soliciting testing proposals for a
consent agreement to perform dermal absorption testing on the 25
chemicals designated in the Thirty-Fifth Report. While solicitation is
separate from the solicitation of interested parties made for the 24
substances designated in the Thirty-First ITC Report published May 5,
1993 (58 FR 26898), and the 34 substances designated in the Thirty-
Second Report published July 16, 1993 (58 FR 38490), EPA expects that
any testing consent agreement adopted for this effort, as well as the
testing method referenced, will be substantially similar. (Note: Two of
these chemicals were removed in the Thirty-Fourth Report). Following
publication of this notice, manufacturers and/or processors have 60
days to develop and submit testing proposals for any of the chemical
substances designated in the Thirty-Fifth Report that they wish EPA to
consider as candidates for consent agreement negotiations.
Federal scientists from a number of the ITC's statutory and liaison
organizations, including the Consumer Product Safety Commission,
Environmental Protection Agency, Food and Drug Administration, National
Institute of Occupational Safety and Health, and Occupational Safety
and Health Administration, have developed a proposed test protocol that
will provide data needed by several U.S. Government Organizations
represented on the ITC. This proposed protocol is entitled ``Protocol
for in vitro Percutaneous Absorption Studies'' and is available to the
public through the TSCA Nonconfidential Information Center and the
Environmental Assistance Division listed above. This document should be
reviewed before submitting any testing proposals in response to this
notice.
Comments on the proposed protocol that were submitted in response
to the Thirty-First ITC Report (Docket OPPTS 41038) and the Thirty-
Second ITC Report (Docket OPPTS 41039) will be incorporated in the
docket for this notice and need not be resubmitted.
For additional technical information on this testing protocol
contact Dr. John D. Walker, Executive Director, TSCA Interagency
Testing Committee, (202) 260-1820.
All testing proposals submitted should describe the testing to be
performed and explain any deviations from the test protocol that are
necessary to assure the development of reliable percutaneous absorption
data.
EPA will review the submissions and select the most promising
submissions as candidates for negotiation. Submissions that fully
address the ITC's concerns will have a higher chance of success than
those that do not fully address all data needs.
3. Negotiation of testing program and development of a testing
consent agreement. EPA will follow the negotiation procedures under 40
CFR 790.22, and to the extent feasible, the timetable outlined in 40
CFR part 790, appendix A to subpart B.
For additional information about process or negotiations contact
Frank Kover, Chief, Chemical Testing and Information Branch, (202) 260-
8130.
Authority: 15 U.S.C. 2603.
Dated: December 20, 1994.
Charles M. Auer,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
Administrator, U.S. Environmental Protection Agency
SUMMARY: This is the 35th Report of the TSCA Interagency Testing
Committee (ITC) to the Administrator of the U.S. Environmental
Protection Agency (EPA). In this Report, the ITC is revising its TSCA
section 4(e) Priority Testing List by designating a group of 25
chemicals for dermal absorption testing because they are of regulatory
interest to the Occupational Safety and Health Administration (OSHA).
The ITC is also revising its List by removing recommended chemicals,
including 28 of 43 isocyanates, 27 of 89 aldehydes, 25 of 26 sulfones,
7 of 11 cyanoacrylates, 4 of 14 diaryl ethers and 19 of 35 chemicals
originally recommended for subchronic (90-day) toxicity testing.
I. Background
The TSCA Interagency Testing Committee (ITC) was established by
section 4(e) of the Toxic Substances Control Act (TSCA) ``to make
recommendations to the Administrator respecting the chemical substances
and mixtures to which the Administrator should give priority
consideration for the promulgation of a rule for testing under section
4(a).... At least every 6 months..., the Committee shall make such
revisions in the List as it determines to be necessary and to transmit
them to the Administrator together with the Committee's reasons for the
revisions'' (Public Law 94-469, 90 Stat. 2003 et seq., 15 U.S.C. 2601
et seq.). Since its creation in 1976, the ITC has submitted 34 semi-
annual Reports to the EPA Administrator transmitting the Priority
Testing List and its revisions. These Reports have been published in
the Federal Register and are available from the ITC. The ITC meets
monthly and produces its revisions with the help of staff and technical
contract support provided by EPA. ITC membership and support personnel
are listed at the end of this Report.
Following receipt of the ITC's Report and the addition of chemicals
to the Priority Testing List, the EPA's Office of Pollution Prevention
and Toxics adds new chemicals from the List to TSCA section 8(a) and
8(d) rules that require manufacturers, processors, and/or distributors
of these chemicals to submit TSCA section 8(a) production and exposure
data and TSCA section 8(d) health and safety studies, within 60 days of
the rule's effective date. The submissions are indexed and maintained
by EPA. The ITC reviews the section 8(a) and 8(d) information and other
available data on chemicals and chemical groups (e.g., TSCA section
8(e) ``substantial risk'' studies, ``For Your Information'' (FYI)
submissions to EPA, and published papers) to determine if revisions to
the List are necessary. Revisions can include changing a recommendation
to a designation for action by the Administrator within 12 months,
modifying the recommended testing, or removing the chemical or chemical
group from the List.
II. Revisions to the TSCA Section 4(e) Priority Testing List
The ITC's revisions to its TSCA Section 4(e) Priority Testing List
are summarized in Table 1.
Table 1.--Chemicals Designated or Removed From the TSCA Section 4(e)
Priority Testing List
------------------------------------------------------------------------
Chemical/Group Action Date
------------------------------------------------------------------------
25 Chemicals with insufficient Designate for Dermal Absorption 11/94
dermal absorption data. Testing
28 Isocyanates................. Remove Previously Recommended 11/94
Chemicals
25 Sulfones.................... Remove Previously Recommended 11/94
Chemicals
18 Chemicals with insufficient Remove Previously Recommended 11/94
subchronic (90-day) toxicity Chemicals
data.
27 Aldehydes................... Remove Previously Recommended 11/94
Chemicals
7 Cyanoacrylates............... Remove Previously Recommended 11/94
Chemicals
4 Diaryl ethers................ Remove Previously Recommended 11/94
Chemicals
------------------------------------------------------------------------
III. Rationale for the Revisions
A. ITC's Activities During this Reporting Period
During the 6 months covered by this Report, May through October
1994, the ITC reviewed dermal absorption data for 63 chemicals with
dermal LD50 values and 1989 production volumes greater than 1
million pounds. The ITC also reviewed the TSCA section 8(a) and section
8(d) submissions and other available data for 43 isocyanates that were
recommended in the ITC's 26th Report (55 FR 23050, June 5, 1990) as
well as 26 sulfones and 35 chemicals with insufficient subchronic (90-
day) toxicity data that were recommended in the ITC's 27th Report (56
FR 9534, March 6, 1991). In addition, the ITC reviewed the production
volume data obtained under the 1990 TSCA Inventory Update Rule and TSCA
section 8(a) Preliminary Assessment Information Reporting rules for 89
aldehydes that were recommended in the ITC's 27th Report, 11
cyanoacrylates that were recommended in the ITC's 28th Report (56 FR
41212, August 19, 1991) and 14 diaryl ethers that were recommended in
the ITC's 29th Report (56 FR 67424, December 30, 1991). Based on these
reviews, the ITC decided which chemicals in these groups to designate
for testing, to retain on the Priority Testing List or to remove from
the List.
B. Specific Rationales
1. Designated chemicals--a. Chemicals with insufficient dermal
absorption data. OSHA previously established Permissible Exposure
Limits (PELs) for chemical substances and mixtures to limit workers'
exposure to industrial chemicals. In general, PELs are based on
inhalation of airborne dusts and vapors. In those cases where chemical
absorption through the skin could be harmful, the chemicals with PELs
are assigned skin notations. OSHA needs quantitative measures of dermal
absorption to evaluate potential hazards to workers.
In September 1991, OSHA nominated chemical substances and mixtures
with PELs to the ITC to assess the availability of dermal absorption
data. OSHA requested that ITC use its TSCA section 4(e) statutory
authority to designate chemicals with insufficient dermal absorption
data for priority testing consideration. As described in previous ITC
reports, the chemicals were organized into groups to facilitate review.
In its 31st report, the ITC designated a group of 24 chemicals for
dermal absorption testing for which no dermal toxicity or absorption
data could be located in the publicly available literature. In its 32nd
report, the ITC designated a group of 34 chemicals for dermal
absorption testing because existing dermal toxicity and absorption data
were insufficient for OSHA's needs. In the 34th report, the ITC removed
two of the previously designated chemicals from the Priority Testing
List because dermal absorption data to meet OSHA's needs were obtained.
Over the past year, the ITC began to review a group of 429
chemicals that have rabbit dermal LD50 values in RTECS. Relevant
information regarding dermal absorption, production volume, exposure
and use, health effects and physicochemical properties were evaluated.
The ITC reviewed 63 of these chemicals, all of which had 1989
production volumes greater than 1 million pounds, and is designating 25
chemicals determined to have insufficient dermal absorption data to
meet OSHA's needs in the following Table 2. The ITC is continuing to
review the remaining chemicals.
Table 2.--Chemicals With Insufficient Dermal Absorption Data That Are
Being Designated for Dermal Absorption Testing
------------------------------------------------------------------------
CAS No. Chemical Name
------------------------------------------------------------------------
75-05-8............................ Acetonitrile
75-12-7............................ Formamide
75-35-4............................ Vinylidene chloride
77-73-6............................ Dicyclopentadiene
78-59-1............................ Isophorone
78-83-1............................ Isobutyl alcohol
78-87-5............................ Propylene dichloride
91-20-3............................ Naphthalene
92-52-4............................ Biphenyl
95-50-1............................ o-Dichlorobenzene
96-18-4............................ 1,2,3-Trichloropropane
98-29-3............................ t-Butylcatechol
99-08-1............................ m-Nitrotoluene
99-99-0............................ p-Nitrotoluene
106-46-7........................... p-Dichlorobenzene
107-06-2........................... Ethylene dichloride
108-93-0........................... Cyclohexanol
108-94-1........................... Cyclohexanone
110-12-3........................... Methyl isoamyl ketone
120-80-9........................... Catechol
121-69-7........................... Dimethylaniline
123-42-2........................... Diacetone alcohol
127-19-5........................... Dimethyl acetamide
542-92-7........................... Cyclopentadiene
34590-94-8......................... Dipropylene glycol methyl ether
------------------------------------------------------------------------
2. Removal of chemicals from the Priority Testing List--a.
Previously recommended chemicals for which production volume and
exposure data and health and safety studies have been reviewed. For
three previously recommended chemical groups (isocyanates, sulfones and
chemicals with insufficient subchronic (90-day) toxicity data), the ITC
reviewed the 1989 production volume data that were submitted in
response to EPA's September 27, 1990, TSCA section 8(a) Partial
Inventory Update Rule (55 FR 39586). In addition, the ITC reviewed the
production and exposure data and health and safety studies that were
submitted in response to EPA's September 28, 1990, TSCA section 8(a)
Preliminary Assessment Information Reporting (PAIR) Rule and TSCA
section 8(d) Health and Safety Data Reporting Rule for isocyanates (55
FR 39586) and EPA's August 29, 1991, PAIR and Health and Safety Data
Reporting Rule for sulfones and chemicals with insufficient subchronic
(90-day) toxicity data (56 FR 42688). For these chemical groups, the
ITC also requested, received and reviewed, use and exposure data from
several companies, studies that have been published since the ITC
recommended these chemicals for testing, TSCA section 8(e) and FYI
studies, unpublished data from tests conducted by the U.S. Government
organizations represented on the ITC and data from the 1981-1983
National Occupational Exposure Survey (NOES). After reviewing these
data and considering the data needs of U.S. Government organizations
represented on the ITC, the ITC decided which chemicals in these groups
should be removed from the Priority Testing List. The chemicals in
these groups that were removed from the List and the rationales for
removing them are described below.
1. Isocyanates. The ITC transmitted its 26th Report to the EPA
Administrator on May 8, 1990, and recommended a group of 43 isocyanates
for physical and chemical property testing in response to a nomination
from the EPA to support its TSCA New Chemicals Program. (55 FR 23050,
June 5, 1990). The ITC is removing 27 isocyanates from the Priority
Testing List because annual production volumes were less than 1 million
pounds or there appeared to be low potential for exposure. The ITC is
also removing methyl isocyanate from the List because its physical and
chemical properties appear to be well characterized. The 28 isocyanates
that ITC is removing from the List are included in the following Table
3.
Table 3.--Isocyanates removed from the Priority Testing List
------------------------------------------------------------------------
CAS No. Chemical Name
------------------------------------------------------------------------
91-97-4............................ 4,4'-Diisocyanato-3,3'-
dimethylbiphenyl
100-28-7........................... p-Nitrophenyl isocyanate
104-49-4........................... p-Phenylene diisocyanate
109-90-0........................... Ethyl isocyanate
110-78-1........................... n-Propyl isocyanate
112-96-9........................... Octadecyl isocyanate
123-61-5........................... 1,3-Diisocyanatobenzene
614-68-6........................... 1-Isocyanato-2-methylbenzene
622-58-2........................... 1-Isocyanato-4-methylbenzene
624-83-9........................... Methyl isocyanate
1476-23-9.......................... 3-Isocyanato-1-propene
2422-91-5.......................... 1,1',1''-Methylidynetris(4-
isocyanatobenzene)
2493-02-9.......................... 1-Bromo-4-isocyanatobenzene
2909-38-8.......................... 1-Chloro-3-isocyanatobenzene
2949-22-6.......................... Ethyl isocyanatoacetate
4151-5............................. 1-3-Tris(4-isocyanatophenyl)
thiophosphate
10031-75-1......................... Diphenylmethylene diisocyanate
15646-96-5......................... 1,6-Diisocyanato-2,4,4-
trimethylhexane
16938-22-0......................... 1,6-Diisocyanato-2,2,4-
trimethylhexane
25854-16-4......................... Bis(isocyanatomethyl)benzene
26603-40-7......................... 1,3,5-Tris(3-
isocyanatomethylphenyl)-1,3,5-
triazine-2,4,6(1H,3H,5H)-trione
26747-90-0......................... Toluene diisocyanate dimer
28178-42-9......................... 2,6-Diisopropylphenyl isocyanate
28556-81-2......................... 2-Isocyanato-1,3-dimethylbenzene
30674-80-7......................... 2-Isocyanatoethyl methacrylate
34893-92-0......................... 3,5-Dichlorophenyl isocyanate
68239-06-5......................... 2-Heptyl-3,4-bis(9-isocyanatononyl)-
1-pentylcyclohexane
73597-26-9......................... Isophorone diisocyanate,
hydroxyethyl methacrylate adduct
------------------------------------------------------------------------
2. Sulfones. In its 27th Report, the ITC recommended a group of 26
sulfones for physical and chemical property testing to estimate whether
occupational exposures or environmental releases were likely to occur
(56 FR 9534, March 6, 1991). This recommendation was based on the
results of the ITC's 6th Scoring Exercise and the use of the ITC's
Substructure-based Computerized Chemical Selection Expert System
(SuCCSES) to identify chemical groups with common chemical
substructures, common exposure or adverse effects potentials and common
data insufficiencies. The Scoring Exercise and SuCCSES have been
previously described by Walker and Brink (Ref. 1) and Walker (Refs. 2
and 3). SuCCSES was used to identify sulfones with insufficient
physical/chemical properties. Based on a review of the data and other
considerations, the ITC is removing 25 sulfones from the Priority
Testing List that are listed in the following Table 4.
Table 4.-- Sulfones Removed from the Priority Testing List
------------------------------------------------------------------------
CAS No. Chemical Name
------------------------------------------------------------------------
Sulfones removed because there
appeared to be low exposure
potential based on annual
production volume and NOES data:
67-71-0.......................... Dimethylsulfone
80-08-0.......................... 4,4'-Diaminodiphenyl sulfone
98-30-6.......................... 2-Amino-4-(methylsulfonyl)phenol
127-63-9......................... Diphenylsulfone
2580-77-0........................ 2,2'-Sulfonyl bisethanol
3278-22-6........................ 1,1'-[Methylene
bis(sulfonyl)]bisethene
5246-57-1........................ 2-[(3-Aminophenyl)sulfonyl]-ethanol
16588-67-3....................... 3-[N-Ethyl-4-[[6-(methylsulfonyl)-2-
benzothiazolyl]azo]-m-toluidino]-
propionitrile
17557-67-4....................... 6-Methylsulfonyl)-2-
benzothiazolamine
17601-96-6....................... 2-Amino-4-[(2-
hydroxyethyl)sulfonyl]phenol
17688-68-5....................... 4-Phenylthiomorpholine, 1,1-dioxide
17741-62-7....................... 4-[4-[(2,6-Dichloro-4-
nitrophenyl)azo]phenyl]-
thiomorpholine, 1,1-dioxide-
20018-09-1....................... 1-(Diiodomethyl)sulfonyl-4-methyl
benzene
26750-50-5....................... 1,1'-[Oxybis(methylenesulfonyl)]
bisethene
36724-43-3....................... 2,2'-[Oxybis(methylenesulfonyl)]
bisethanol
41123-59-5....................... 1,1'-[Methylenebis(sulfonyl)] bis-2-
chloroethane
41123-69-7....................... 2,2'-[Methylenebis(sulfonyl)]
bisethanol
41687-30-3....................... 2-[(3-Nitrophenyl)sulfonyl] ethanol
52218-35-6....................... 2-[(6-Amino-2-
naphthalenyl)sulfonyl] ethanol
53061-10-2....................... 1,1'-[Oxybis(methylenesulfonyl)]
bis-2-chloroethane
63134-33-8....................... 4-[[4-(Phenylmethoxy)phenyl]-
sulfonyl] phenol
Sulfones removed because testing
recommendations are currently a
lower priority than others:
77-79-2.......................... Sulfolene
80-09-1.......................... Bisphenol S
126-33-0......................... Sulfolane
18760-44-6......................... 3-(Decyloxy)tetrahydrothiophene 1,1-
dioxide
------------------------------------------------------------------------
3. Chemicals previously recommended for subchronic (90-day)
toxicity testing. On May 17, 1987, the ITC convened a public meeting to
discuss the results of the its 6th Scoring Exercise, development of
SuCCSES and a list of 166 substantially produced chemicals (i.e.,
chemicals with 1985 production volumes > 1 million pounds) that were
coded in SuCCSES for exposure and adverse effects potentials. Based on
a review of available data, the ITC recommended a group of 35 chemicals
in its 27th Report that did not have 90-day subchronic toxicity test
data (56 FR 9534, March 6, 1991). Based on a review of the data
submitted to EPA and other considerations, the ITC is removing 18
chemicals from the Priority Testing List that are listed in the
following Table 5.
Table 5.--Chemicals Previously Recommended for Subchronic (90-day)
Toxicity Testing Removed from the Priority Testing List
------------------------------------------------------------------------
CAS No. Chemical Name
------------------------------------------------------------------------
Chemicals removed because there
appeared to be low exposure
potential based on annual
production volume and use data:
84-51-5.......................... 2-Ethylanthraquinone
87-02-5.......................... 7-Amino-4-hydroxy-2-
naphthalenesulfonic acid
95-32-9.......................... 2-(4-Morpholinyldithio)-
benzothiazole
98-48-6.......................... 1,3-Benzenedisulfonic Acid
99-63-8.......................... Isophthaloyl chloride
100-20-9......................... Terephthaloyl chloride
106-31-0......................... Butyric anhydride
116-81-4......................... Bromamine acid
123-62-6......................... Propanoic anhydride
616-21-7......................... 1,2-Dichlorobutane
760-23-6......................... 3,4-Dichlorobutene
1111-78-0........................ Ammonium carbamate
Chemicals removed because Screening
Information Data Set dossiers have
been developed and the need for 90-
day subchronic toxicity tests will
be considered by representatives
from OECD countries that review
these dossiers:
92-70-6.......................... 3-Hydroxy-2-naphthoic acid
102-01-2......................... Acetoacetanilide
Chemicals removed because
subchronic (90-day) toxicity
testing recommendations are
currently a lower priority than
other:
123-54-6......................... 2,4-Pentanedione
311-89-7......................... Perfluorotributylamine
355-42-0......................... Perfluoro-N-hexane
1047-16-1........................ Quinacridone
------------------------------------------------------------------------
b. Previously recommended chemicals for which production volume
data have been reviewed. For three previously recommended chemical
groups (aldehydes, cyanoacrylates and diaryl ethers), the ITC reviewed
the 1989 production volume data that were submitted in response to
EPA's September 27, 1990, TSCA section 8(a) Partial Inventory Update
Rule (55 FR 39586). In addition, the ITC reviewed the production and
exposure data that were submitted in response to EPA's August 29, 1991
PAIR rule for aldehydes (56 FR 42688), to EPA's December 27, 1993 PAIR
rule for cyanoacrylates (58 FR 68317) and to EPA's March 12, 1993 PAIR
rule for diaryl ethers (58 FR 13556). After reviewing these data, the
ITC decided to remove chemicals in these groups from the Priority
Testing List that had production volumes less than 10,000 pounds per
year.
1. Aldehydes. The ITC submitted its 27th Report to the EPA
Administrator on November 19, 1990, and recommended a group of 89
aldehydes for aquatic toxicity testing in response to a nomination from
the EPA to support its TSCA New Chemicals Program (56 FR 9534, March 6,
1991). Based on a review of production volume data, the ITC is removing
27 aldehydes from the Priority Testing List. These aldehydes are listed
in the following Table 6.
Table 6.--Aldehydes removed from the Priority Testing List
------------------------------------------------------------------------
CAS No. Chemical Name
------------------------------------------------------------------------
66-77-3............................ 1-Naphthalenecarboxaldehyde
78-85-3............................ 2-Methyl-2-Propenal
93-53-8............................ Methyl-benzeneacetaldehyde
95-01-2............................ 2,4-Dihydroxybenzaldehyde
97-51-8............................ 2-Hydroxy-5-nitrobenzaldehyde
98-03-3............................ 2-Thiophenecarboxaldehyde
99-72-9............................ 4-Methylbenzeneacetaldehyde
106-26-3........................... 3,7-Dimethyl-2,6-Octadienal, (Z)-
106-72-9........................... 2,6-Dimethyl-5-heptenal
123-08-0........................... 4-Hydroxybenzaldehyde
135-02-4........................... 2-Methoxybenzaldehyde
141-27-5........................... 3,7-Dimethyl-2,6-octadienal, (E)-
143-14-6........................... 9-Undecenal
455-19-6........................... 4-(Trifluoromethyl)benzaldehyde
505-57-7........................... 2-Hexenal
552-89-6........................... 2-Nitrobenzaldehyde
1121-60-4.......................... 2-Pyridinecarboxaldehyde
1200-14-2.......................... 4-Butylbenzaldehyde
1334-78-7.......................... Methylbenzaldehyde
1423-46-7.......................... 2,4,6-Trimethyl-3-cyclohexene-1-
carboxaldehyde
5435-64-3.......................... 3,5,5-Trimethylhexanal
5780-07-4.......................... 7-Methoxy-1,3-benzodioxole-5-
carboxaldehyde
5949-05-3.......................... 3,7-Dimethyl-6-Octenal, (S)-
5988-91-0.......................... 3,7-dimethyloctanal
10031-82-0......................... 4-Ethoxybenzaldehyde
28602-27-9......................... (Dimethylamino)benzaldehyde
37677-14-8......................... 4-4-Methyl-3-pentenyl)-3-
cyclohexene-1-carboxaldehyde
------------------------------------------------------------------------
2. Cyanoacrylates. In its 28th Report, the ITC recommended a group
of 11 cyanoacrylates for physical and chemical property testing. The
ITC's recommendation was based on concerns and uncertainties related to
production and use, potential exposures and releases from production,
processing and use (56 FR 41212, August 19, 1991). Based on a review of
production volume data, the ITC is removing 7 cyanoacrylates from the
Priority Testing List. These cyanoacrylates are listed in the following
Table 7.
Table 7.--Cyanoacrylates Removed from the Priority Testing List
------------------------------------------------------------------------
CAS No. Chemical Name
------------------------------------------------------------------------
1069-55-2................... 2-Propenoic acid, 2-cyano-, isobutyl ester
(isobutyl cyanoacrylate)
6606-65-1................... 2-Propenoic acid, 2-cyano-, butyl ester
(butyl cyanoacrylate)
7324-02-9................... 2-Propenoic acid, 2-cyano-, 2-propenyl
ester (allyl cyanoacrylate)
10586-17-1.................. 2-Propenoic acid, 2-cyano-, 1-methylethyl
ester (isopropyl cyanoacrylate)
21982-43-4.................. 2-Propenoic acid, 2-cyano-, ethoxy ethyl
ester (ethoxy ethyl cyanoacrylate)
23023-91-8.................. 2-Propenoic acid, 2-cyano-, 2,2,2-
trifluomethyl ester (2,2,2-
trifluoromethyl cyanoacrylate)
27816-23-5.................. 2-Propenoic acid, 2-cyano-, methyoxy ethyl
ester (methoxy ethyl cyanoacrylate)
------------------------------------------------------------------------
3. Diaryl ethers. In its 29th Report, the ITC recommended a group
of 14 alkyl, bromo, chloro, or hydroxy-methyl diaryl ethers for
physical chemical property, biodegradation rate, health effects and
ecological effects screening tests (56 FR 67424, December 30, 1991).
This recommendation was based on an analysis of data in SuCCSES that
was compiled during the ITC's 6th Scoring Exercise. Based on a review
of production volume data, the ITC is removing 4 diaryl ethers from the
Priority Testing List. These diaryl ethers are listed in the following
Table 8.
Table 8.--Diaryl Ethers Removed from the Priority Testing List
------------------------------------------------------------------------
CAS No. Chemical Name
------------------------------------------------------------------------
3061-36-7............................. 1,4-Diphenoxybenzene
50789-44-1............................ 3-Phenoxybenzene methanol
acetate
61702-88-3............................ 1,1'-Oxybis(1,1,3,3-
tetramethylbutyl)benzene
69834-19-1............................ 1,1'-Oxybisdodecylbenzene
------------------------------------------------------------------------
References
(1) Walker, J.D. and Brink, R.H. ``New Cost-Effective,
Computerized Approaches to Selecting Chemicals for Priority Testing
Consideration,'' In: Aquatic Toxicology and Environmental Fate:
Eleventh Volume, ASTM STP 1007, G. W. Suter, II and M.A. Lewis,
Eds., American Society for Testing and Materials, Philadelphia, PA,
pp. 507-536 (1989).
(2) Walker, J.D. ``Chemical Selection by the TSCA Interagency
Testing Committee: Use of Computerized Substructure Searching to
Identify Chemical Groups for Health Effects, Chemical Fate and
Ecological Effects Testing,'' Science of the Total Environment: Vol.
109/110, pp. 691-700 (1991).
(3) Walker, J.D. ``The TSCA Interagency Testing Committee, 1977
to 1992: Creation, Structure, Functions and Contributions,'' In:
Environmental Toxicology and Risk Assessment: Second Volume, ASTM
STP 1216, J.W. Gorsuch, F.J. Dwyer, C.G. Ingersoll and T.W. LaPoint,
Eds., American Society for Testing and Materials, Philadelphia, PA,
pp. 451-509 (1993).
IV. The TSCA Section 4(e) Revised Priority Testing List
The revised TSCA section 4(e) Priority Testing List follows.
The TSCA Section 4(e) Priority Testing List (November 1994)
------------------------------------------------------------------------
Report Date Chemical/Group Action
------------------------------------------------------------------------
23.............. November 1988 Butyraldehyde Recommended
23.............. November 1988 Tetrakis(2- Recommended
chloroethyl)ethylen with intent-to-
e diphosphate designate
Tris(1,3-dichloro-2-
propyl) phosphate
Tris(1-chloro-2-
propyl) phosphate
Tris(2-chloro-1-
propyl) phosphate
Tris(2-chloroethyl)-
phosphate
26.............. May 1990 15 Isocyanates Recommended
with intent-to-
designate
27.............. November 1990 62 Aldehydes Recommended
with intent-to-
designate
27.............. November 1990 Sulfonyl bis(4- Recommended
chlorobenzene)
27.............. November 1990 17 Chemicals with Recommended
insufficient
subchronic (90-day)
toxicity data
28.............. May 1991 Acetone Designated
28.............. May 1991 Thiophenol Designated
28.............. May 1991 m-Dinitrobenzene Recommended
28.............. May 1991 14 Cyanoacrylates Recommended
29.............. November 1991 10 Alkyl-, bromo-, Recommended
chloro-,
hydroxymethyl
diaryl ethers
30.............. May 1992 56 Siloxanes Recommended
30.............. May 1992 25 Chloroalkyl Recommended
phosphates
31.............. January 1993 24 Chemicals with no Designated
dermal toxicity
data
31.............. January 1993 13 Propylene glycol Recommended
ethers and esters
31.............. January 1993 32 Methyl ethylene Recommended
glycol ethers and
esters
32.............. May 1993 32 Chemicals with Designated
insufficient dermal
absorption data
34.............. May 1994 White phosphorus Designated
34.............. May 1994 Ethyl tert-butyl Recommended
ether
34.............. May 1994 Tert-amyl methyl Recommended
ether
35.............. November 1994 25 Chemicals with Designated
insufficient dermal
absorption data
------------------------------------------------------------------------
TSCA Interagency Testing Committee
Statutory Organizations and Their Representatives
Council on Environmental Quality
Elisabeth Blaug, Member
Department of Commerce
Edward White, Member
Willie E. May, Alternate
Environmental Protection Agency
David R. Williams, Member
Lois Dicker, Alternate
National Cancer Institute
Harry Seigried, Member
Richard Adamson, Alternate
National Institute of Environmental Health Sciences
Errol Zeiger, Member, Vice Chair
H.B. Matthews, Alternate
National Institute for Occupational Safety and Health
Henryka Nagy, Member
David A. Dankovic, Alternate
National Science Foundation
Linda Duguay, Member
Occupational Safety and Health Administration
Christine Whittaker, Member, Chair
Liaison Organizations and Their Representatives
Agency for Toxic Substances and Disease Registry
William Cibulas, Member
Consumer Product Safety Commission
Val Schaeffer, Member
Lakshmi C. Mishra, Alternate
Department of Agriculture
Donald Derr, Member
Clifford Rice, Alternate
Department of Defense
David A. Macys, Member
James N. McDougal, Alternate
Department of the Interior
Barnett A. Rattner, Member
Food and Drug Administration
Edwin J. Matthews, Member
Raju Kammula, Alternate
National Library of Medicine
Vera Hudson, Member
National Toxicology Program
Victor A. Fung, Member
Counsel
Mary Ellen Levine, Office of General Counsel, EPA
Technical Support Contractor
Syracuse Research Corporation
ITC Staff
John D. Walker, Executive Director
Norma S.L. Williams, Executive Assistant, TSCA Interagency
Testing Committee U.S. EPA/OPPT (MC 7401) 401 M Street, S.W.
Washington, D.C. 20460 Phone (202) 260-1825 Fax (202) 260-7895
Internet walker.johnd@epamail.epa.gov
[FR Doc. 94-32117 Filed 12-28-94; 8:45 am]
BILLING CODE 6560-50-F
